March 9, 2011

Travel Day

Welcome to another day in my life. Today is Wednesday and we have almost made it through the middle of another work week. I hope you are having a safe and great week so far.

Today is a travel day for Dab the AIDS Bear and me. We are flying from Fort Lauderdale to Pensacola, Florida on Delta airlines. I will be visiting with my Dad for a day before heading to the Positive Living Conference in Fort Walton Beach, Florida.

I blogged about doctors using Truvada as a medicine for HIV prevention. Well I read another article yesterday that this course of action is not going well.

Gilead Sciences Inc.’s Truvada topped Time magazine’s list of medical breakthroughs for 2010 after a study showed it may achieve a goal pursued by scientists for a quarter century: a pill to prevent HIV infection.

Three months later, the advance has hit a wall. While study findings show the drug prevents HIV in non-infected, sexually active gay men, doctors say they are wary about giving healthy people a $12,000 a year medicine that has side effects including nausea and kidney damage, and may not be used as regularly as needed. They also say they are not often asked to make the drug available for that use.

“We are not seeing people beating down the doors,” said Kenneth Mayer, medical research director and co-chair of The Fenway Institute, a clinic that serves 15,000 people in Boston, including several thousand gay men. While a few patients have asked about using Truvada for prevention, perhaps for their healthy partners, Mayer says he does not know any clinic doctor who has prescribed it that way.

The issue is central this week at the Conference on Retroviruses and Opportunistic Infections, or CROI, a meeting for AIDS doctors that began yesterday in Boston. A dozen presentations are scheduled that will examine Truvada’s long term use in uninfected people, its’ side effects and safety, the best candidates for it and the potential risk of developing drug-resistance with inconsistent use.

Powerful Data

The study was beautifully done and the data are powerful, but, so far, it raises more questions than it answers. People who can not use a condom, are they likely to take a pill every day? And in the real world, who will pay?

Healthy men who took Truvada regularly and had detectable levels in their blood were 92 percent less likely to get the AIDS causing virus than those who took the drug sporadically or received a placebo, according to a study published in the New England Journal of Medicine in November.

Overall the research found the medicine cut infection risk by 44 percent in 2,500 gay men who were prescribed it preemptively for one to three years.

Truvada combines Viread and Emtriva, two drugs made by Foster City, California based Gilead, into a single blue pill. It has been used since 2004 to reduce levels of HIV in people infected with the AIDS causing virus. Researchers in the study theorized that Truvada, taken preemptively, may prevent HIV from gaining a foothold when it first enters the body, averting infection that requires a lifetime of treatment.

Second Biggest Product

The medicine was Gilead’s second best selling product last year with $2.6 billion in revenue. The company plans to file for U.S. approval as a preventative in the first half of 2011, said Chief Executive Officer John C. Martin in the company’s Jan. 25 earnings call.

In November, soon after the study was reported, Robyn Karnauskas, a Deutsche Bank Securities analyst in New York, said the finding may add $1 billion to Truvada’s sales. The shares in 2011 have risen 7.6 percent before today, compared with the S&P 500 Pharmaceutical Index, which has been little changed.

Use of the drug, though, has increased only slightly, according to data compiled by Bloomberg.

Between 6,805 and 8,107 new prescriptions were written each week for Truvada from December 1, 2010, to Feb. 19, generating $8.7 million to $10.3 million in sales, the data shows. That’s a rise from 5,819 to 7,698 prescriptions, with sales of $6.9 million to $9.2 million, during the same period a year earlier.

Giant Question Mark

In terms of the market potential, it is a giant question mark. It is essentially a pipeline product of unknown value. A whole lot of data needs to be filled in before we know how big this could be.

Gilead fell 3 cents, or less than one percent, to $38.98 at 4 p.m. New York time in Nasdaq Stock Market composite trading.

Gilead spokeswoman Amy Flood said in a telephone interview the company can’t track sales of Truvada for prevention.

During the earnings call, Martin said Gilead does not view Truvada’s new use as a significant commercial opportunity. Nonetheless, he said, the company does see it as an important contribution to management of the HIV epidemic worldwide.

Karnauskas said she based her estimate on the assumption that 5 percent of uninfected gay men would take the drug 30 percent of the time. That is not happening yet, Mayer said in a telephone interview.

I will conclude this blog tomorrow.

Until we meet again; here's wishing you health, hope, happiness and just enough.